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Structural Heart
Transcatheter therapies for valvular and structural heart disease.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Structural heart refers to minimally-invasive, catheter-based therapies that repair or replace cardiac valves and close structural defects - TAVR, transcatheter mitral and tricuspid repair/replacement, left atrial appendage closure (LAAC), and PFO/ASD closure. Most of these are Class III devices that need PMA approval, and coverage often relies on national coverage determinations with registry requirements. Heart team evaluation and operator training are central to adoption. What the regulation says
Structural heart devices, encompassing technologies like transcatheter aortic valve replacement (TAVR) and devices for repairing or replacing other cardiac valves or closing structural defects, are subject to stringent regulatory oversight by bodies such as the FDA in the United States and under the EU Medical Device Regulation (EU MDR) in Europe. Manufacturers must demonstrate safety and effectiveness through robust clinical trials, adhering to requirements outlined in documents like 21 CFR Part 812 for investigational device exemptions and EU MDR Annex I for general safety and performance requirements. Specific guidance documents may exist for particular device types within this segment, addressing pre-market approval (PMA) or conformity assessment pathways.What this means in practice
TAVR (Edwards SAPIEN, Medtronic CoreValve) transformed aortic stenosis treatment. Mitral and tricuspid programs are the next major growth drivers. Reimbursement is generally favorable through MS-DRGs and dedicated NTAPs early in launch.Examples
- A company developing a new transcatheter mitral valve replacement (TMVR) device conducts a pivotal clinical trial to gather safety and efficacy data for its PMA submission to the FDA.
- A manufacturer of an atrial septal defect (ASD) closure device updates its technical documentation to align with the new general safety and performance requirements of the EU MDR, undergoing a conformity assessment with a Notified Body.
- Prior to market release, a structural heart device with remote monitoring capabilities undergoes a thorough cybersecurity vulnerability assessment to comply with FDA pre-market submission requirements for medical device cybersecurity.
Common pitfalls
- •A common pitfall is underestimating the complexity of clinical trial design and execution required for novel structural heart devices, leading to significant delays in market access.
- •Failing to adequately address post-market surveillance requirements, such as those under 21 CFR Part 822 for postmarket surveillance studies or EU MDR Article 83 for post-market surveillance systems, can result in regulatory actions.
- •Inadequate cybersecurity considerations for connected structural heart devices can lead to vulnerabilities, posing risks to patient safety and data integrity, and potentially violating regulations like those concerning medical device security.
- •Manufacturers sometimes overlook the need for comprehensive risk management, as mandated by standards like ISO 14971:2019, specifically addressing the unique risks associated with implantable and life-sustaining structural heart devices.
- •Another mistake is not anticipating the evolving reimbursement landscape and its impact on market adoption, even with favorable initial coverage.
Frequently asked questions
Most novel structural heart devices require a Premarket Approval (PMA) application to the FDA, due to their high-risk classification. This pathway demands extensive clinical evidence of safety and effectiveness.
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Sources
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Tier 4Trade press and expert commentary· 3
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- 1ACC structural heart hubTier 4 VerifiedACCacc.org
- 2AdvaMed - Industry ReportsTier 4 VerifiedAdvaMedadvamed.org
- 3MedTech Europe - Facts & FiguresTier 4 VerifiedMedTech Europemedtecheurope.org
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